Subconjunctival steroid depot after cataract extraction

ISRCTN	ISRCTN41133247
DOI	https://doi.org/10.1186/ISRCTN41133247
Secondary identifying numbers	OZR-2006-01, NL768, NTR779

Submission date: 28/12/2006
Registration date: 28/12/2006
Last edited: 05/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr P W Y de Waard
Scientific

Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands

Phone	+31(0)10 401 7777
Email	deWaard@oogziekenhuis.nl

Study information

Study design	Randomised, controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Subconjunctival steroid depot after cataract extraction
Study objectives	A single subconjunctival Celestone chronodose injection immediately following cataract extraction reduces the incidence of post-operative ocular inflammation when compared with conventional post-operative eye drops therapy. Post-op administration of eserine does not reduce the incidence of dislocation of the intraocular lens implant any further.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Cataract
Intervention	Group 1: subconjunctival steroid injection. Group 2: topical steroids (three times per day during three weeks). Group 3: as group two plus Eserine. Group 4: as group one plus Eserine.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Steroids, Celestone chronodose and Eserine
Primary outcome measure	1. Laser flarecount, examined by laser flarecounter, before operation and on day 21. 2. Thickness of the macula, examined by Optical Coherence Tomography (OCT), before operation and on day 21.
Secondary outcome measures	1. Number of extra visits due to complaints of post-op irritation. 2. Number of patients with macular edema, examined by OCT, on day 21. 3. Intraocular pressure on day one and 21. 4. Number of extra visits due to complaints of reduced visual acuity (miotic wearing off). 5. Pain (scaling one to ten) on day one. 6. Incidence of anterior synechiae (gonioscopic evaluation) on day 21. 7. Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart on day 21.
Overall study start date	01/01/2007
Completion date	30/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	400
Total final enrolment	400
Key inclusion criteria	1. Cataract extraction indication 2. Aged over 18 years 3. Caucasian - informed consent 4. Post-op follow-up must be feasible
Key exclusion criteria	1. Subcapsular posterior cataract (very soft, short phaco time) 2. Brunescens or mature cataract (hard, long phaco time) 3. Diabetes mellitus 4. Age-related macula degeneration 5. History of uveitis 6. Glaucoma 7. History of steroid response 8. Per-operative iris manipulation (e.g. miosis or posterior synechiae) 9. Pre-operative synechiae anterior 10. Systemic steroid medication 11. Chemotherapy 12. Peroperative contact with vitreous 13. Sickle cell anemia 14. Corneal complications 15. Atopy 16. Herpes Simplex Virus (HSV)
Date of first enrolment	01/01/2007
Date of final enrolment	30/06/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Oogziekenhuis Rotterdam

Rotterdam
3011 BH
Netherlands

Sponsor information

The Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (OZR) (The Netherlands)
Hospital/treatment centre

P.O. Box 70030
Rotterdam
3000 LM Rotterdam
Netherlands

Phone	+31 (0)10 401 7777
Email	info@oogziekenhuis.nl
Website	http://www.oogziekenhuis.nl/
"ROR"	https://ror.org/02hjc7j46

Funders

Funder type

Research organisation

Stichting Wetenschappelijk Onderzoek het Oogziekenhuis (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2012	05/01/2021	Yes	No

Editorial Notes

05/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.